PAT


LEADERS SUPPLEMENT


ROUNDTABLE Mario Becker


Vice President Marketing and Product Management – PAT & Automation, Sartorius Group


James Brenner


Product Manager / Applications Chemist, Extrel


Frédéric Despagne


Industry Manager – Life Sciences and Speciality Chemicals,


ABB Measurement Products – Analytical Solutions


Moderator Dave Rudd, GlaxoSmithKline


“PAT/Quality by Design practitioners are still ‘learning their way’ in the pharmaceutical industry and are not always clear what they want from process measurement techniques. How are vendor companies improving their awareness of customer requirements to ensure that appropriate measurement techniques, capable of performing to required standards, are being developed and optimised? As an example, most formulation scientists and process engineers will agree that the quality attributes of a granulation process will include aspects such as porosity, density, wetability etc ... and yet these not easily measured in real- time as suitable techniques do not seem to be available.”


Frédéric Despagne: Two-way communication between industry and vendors is key. Over a decade ago, we acknowledged the specificity of


www.europeanpharmaceuticalreview.com


the industry needs and created a Life Sciences division for analytics. We also have a Centre of Excellence to offer application-specific solutions around pharmaceutical manufacturing. Regular meetings with our end-users in R&D and manufacturing give them opportunities to describe measurement needs that are not properly addressed. Conversely, we show them some possibilities of our analysers that they may not have realised – sometimes by referring to experience in other industries. And as importantly, we have an open exchange concerning the limits of our equipments, in order not to generate wrong expectations.


John Richmond: As a major supplier of PAT solutions to the pharmaceutical industry, Bruker spends much time and effort in educating customers as to potential solutions. We work closely with leading universities and research institutes performing proof-of-principle studies in all areas of pharmaceutical manufacturing. In the granulation example you mention, Bruker


has in fact been collaborating in this area with a leading European University and a supplier of high shear mixers and granulators since 2005. We have discovered that the information rich NIR spectrum makes it possible to correlate both chemical and some physical properties during the granulation process.


Mario Becker: Sartorius as a Total Solution Provider is constantly engaged with pharma - ceutical manufacturers to complete the technology portfolio and provide the needed applications. Especially in the strong growing field of single-use sensor technologies for biopharmaceutical applications, we are developing market driven solutions on the industry’s demands like the new BioPAT®Trace Glucose-Lactate Analyser for Cell Culture applications. When it comes to granulation processes, PAT solutions like the Microwave Resonance Technology for density independent core moisture measurement are the result of joint developments with our customers.


European Pharmaceutical Review 15 Volume 16 | Issue 6 | 2011


John Richmond


Vice President NIR & Process, Bruker Optics Inc


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17